Clindamycin Once a Day in Septic Abortion

Summary

Septic abortion is a serious condition. Women with septic abortion are treated with clindamycin plus gentamicin using divided doses, i.e., thrice a day. The objective of this study is to compare the rates of cure between once or thrice a day use of clindamycin with gentamicin in cases of septic abortion.

Timeline

Start

2014-12-17

Primary completion

2023-12-31

Completion

2023-12-31

Publications

• Background Singh S. Hospital admissions resulting from unsafe abortion: estimates from 13 developing countries. Lancet. 2006 Nov 25;368(9550):1887-92. doi: 10.1016/S0140-6736(06)69778-X.
• Background Ahman E, Shah IH. New estimates and trends regarding unsafe abortion mortality. Int J Gynaecol Obstet. 2011 Nov;115(2):121-6. doi: 10.1016/j.ijgo.2011.05.027. Epub 2011 Aug 31.
• Background Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
• Background Del Priore G, Jackson-Stone M, Shim EK, Garfinkel J, Eichmann MA, Frederiksen MC. A comparison of once-daily and 8-hour gentamicin dosing in the treatment of postpartum endometritis. Obstet Gynecol. 1996 Jun;87(6):994-1000. doi: 10.1016/0029-7844(96)00054-3.
• Background Hemsell DL, Martens MG, Faro S, Gall S, McGregor JA. A multicenter study comparing intravenous meropenem with clindamycin plus gentamicin for the treatment of acute gynecologic and obstetric pelvic infections in hospitalized women. Clin Infect Dis. 1997 Feb;24 Suppl 2:S222-30. doi: 10.1093/clinids/24.supplement_2.s222.
• Background French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. doi: 10.1002/14651858.CD001067.pub2.
• Background Savaris RF, de Moraes GS, Cristovam RA, Braun RD. Are antibiotics necessary after 48 hours of improvement in infected/septic abortions? A randomized controlled trial followed by a cohort study. Am J Obstet Gynecol. 2011 Apr;204(4):301.e1-5. doi: 10.1016/j.ajog.2010.11.017. Epub 2010 Dec 31.
• Background Nicolau DP, Freeman CD, Belliveau PP, Nightingale CH, Ross JW, Quintiliani R. Experience with a once-daily aminoglycoside program administered to 2,184 adult patients. Antimicrob Agents Chemother. 1995 Mar;39(3):650-5. doi: 10.1128/AAC.39.3.650.
• Background Rao SC, Srinivasjois R, Hagan R, Ahmed M. One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD005091. doi: 10.1002/14651858.CD005091.pub3.
• Background Plaisance KI, Drusano GL, Forrest A, Townsend RJ, Standiford HC. Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate. Antimicrob Agents Chemother. 1989 May;33(5):618-20. doi: 10.1128/AAC.33.5.618.
• Background Livingston JC, Llata E, Rinehart E, Leidwanger C, Mabie B, Haddad B, Sibai B. Gentamicin and clindamycin therapy in postpartum endometritis: the efficacy of daily dosing versus dosing every 8 hours. Am J Obstet Gynecol. 2003 Jan;188(1):149-52. doi: 10.1067/mob.2003.88.
• Background Moberg PJ, Gottlieb C, Nord CE. Anaerobic bacteria in uterine infection following first trimester abortion. Eur J Clin Microbiol. 1982 Apr;1(2):82-6. doi: 10.1007/BF02014196.
• Background Soper DE. Postpartum endometritis. Pathophysiology and prevention. J Reprod Med. 1988 Jan;33(1 Suppl):97-100.
• Background Giugno CS, Silva AL, Fuhrich DG, Rabaioli PS, Goncalves KG, Sartor NC, Savaris RF. Daily dose of clindamycin versus standard divided doses in obstetrical and gynecological infections: a retrospective cohort study. Int J STD AIDS. 2013 Nov;24(11):893-8. doi: 10.1177/0956462413487516. Epub 2013 Jul 19.
• Background Grimes DA. The "CONSORT" guidelines for randomized controlled trials in Obstetrics & Gynecology. Obstet Gynecol. 2002 Oct;100(4):631-2. doi: 10.1016/s0029-7844(02)02233-0. No abstract available.
• Background Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1.
• Background Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. doi: 10.1136/bmj.319.7211.670.

Drugs

Indications